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QA Specialist - II
Ref No.: 18-00315
Location: Foster City, California
Position Type:Contract
Title: QA Specialist II
Location: Foster City, CA
Type: Contract

  • Provide support to the Quality Operations Group
  • Support Inspection Readiness, Quality Risk Management and general QA validation oversight of qualifying Facility, Utilities, and Process Equipment.
  • Must have prior experience in the pharmaceutical /biotech industry and a working knowledge of 21cFR210/21CFR211/21CFR Part 11.
  • Additional proficiencies in the use of Word, Excel, Powerpoint, Visio, Maximo, and Trackwise software are desirable.
  • Essential duties include supporting the inspection readiness in the preparation and planning for regulatory inspections, which may include training and logistical support.
  • In addition, the candidate may be required to provide first-line QA review of Equipment, Facilities and Utilities IQ, OQ and PQ documents.
  • Must have strong knowledge of cGMP (FDA, EU and ICH) requirements and the ability to assess compliance risks.
  • Experience in Quality Risk Management and risk-based qualification tools (PHA, FMEA).
  • Experience with implementation/improvement of quality systems.
  • Experience providing QA oversight of facility changes, equipment qualification and lab system validation.
  • Excellent communication skills (both oral and written) including the ability to effectively communicate across organizational levels and functions.
  • Facilitate open communication and sharing of knowledge.
  • Specific Education and Experience: Typically requires a BA or BS degree and minimum 5 years of relevant experience in related field or a MA or MBA degree and minimum 4 years of relevant experience.